Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial

The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.

The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.

In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.

Study Overview

• Status: Completed
• Conditions: Ankle Fracture; Postoperative Treatment
• Intervention / Treatment: Device: 2-week casting followed by 4-week bracing; Device: 6-week casting

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Weber A or B type ankle fracture
• uni-, bi- or trimalleolar injury and/or fibular displacement of >2 mm in any plane on the radiographs

Exclusion Criteria:

• Weber C injury necessitating syndesmotic fixation
• Pilon injury
• Inadequate co-operation
• Other severe concomitant injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bracing group; Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.	Device: 2-week casting followed by 4-week bracing; Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.
Active Comparator: Casting group; Participants in the casting group had a cast for 6 weeks after the surgery.	Device: 6-week casting; Participants in the casting group had a cast for 6 weeks after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olerud-Molander score	Patient-reported outcome measure, 0-100 points, higher points indicating better result.	3 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olerud-Molander score	Patient-reported outcome measure, 0-100 points, higher points indicating better result.	6 weeks and 12 months
Kaikkonen score	Patient-reported outcome measure, 0-100 points, higher points indicating better result.	6 weeks, 3, 12, and 24 months
Swelling of the ankle	Circumference in millimetres compared to unaffected side	6 weeks, 3, 12, and 24 months
Atrophy of the calf muscles	Circumference in millimetres compared to unaffected side	6 weeks, 3, 12, and 24 months
Ankle active dorsiflexion	Degrees compared to unaffected side	6 weeks, 3, 12, and 24 months
Ankle active plantarflexion	Degrees compared to unaffected side	6 weeks, 3, 12, and 24 months
Return-to-work	Days after the injury	Within 24 months
Subjective symptoms and return to activities	The patients were questioned about the subjective symptoms (pain, swelling, stiffness and giving way) and about the compliance of using the cast or brace. In addition the patients were asked about the length of their inability to work and participate in the daily activities and/or sports at the preinjury level.	2 and 6 weeks; 3, 12, and 24 months
Visual Analog Scale for Pain	0-10, higher score indicating more pain.	6 weeks, 3, 12, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Infection, loss of reduction, implant loosening, deep vein thrombosis	2 and 6 weeks; 3, 12, and 24 months

Collaborators and Investigators

• Sponsor: Töölö Hospital
• Collaborators: Tampere University Hospital
• Investigators: Study Chair: Teppo Järvinen, Prof, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2005
• Primary Completion (Actual): June 16, 2010
• Study Completion (Actual): March 16, 2012

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 06121917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No